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临床试验/NCT05804682
NCT05804682已完成不适用

Fascial Versus Standard Neck Dissection in Patients With N1b Papillary Thyroid Carcinoma: a 4-year Analysis of Outcomes.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
1
主要终点
Harvested lymph nodes

研究概览

简要总结

Optimal surgical technique for neck dissection (LND) in thyroid carcinoma remains a subject of debate. Fascial ND (FND) implies the removal of the superficial and middle layers of the deep cervical fascia en bloc with lymph-nodes containing fibro-fatty tissue (levels IIa-Vb and VI-VII for cN1b patients). This retrospective cohort study was designed to compare FND with standard, non-fascial, selective ND (SND).

详细描述

In thyroid cancer patients, lymph node dissection includes a comprehensive removal of all the target nodal basins: anterior cervical compartment (level VI) and the superior mediastinal nodes that can be reached via cervical incision (level VII) in CND, and levels IIa-Vb in LND. Clearance of those levels without including the enveloping fasciae in the specimen is referred to hereafter as Standard Neck Dissection (SND), as it is the most common technique applied for thyroid tumors. In Fascial Neck Dissection, the comprehensive clearance of the target basins is achieved by following the planes of coalescence of the cervical fascial layers. Those are avascular and enable the removal of the target nodes en bloc with their investing fascial layers.

The aim of this retrospective study was to compare the outcomes between fascial and standard approach in N1b PTC patients that underwent surgery for N1b papillary thyroid cancer. The primary objective was to achieve a significantly higher nodal yield by applying the fascial neck dissection technique and reduce rates of early loco-regional recurrence. Secondary objectives were the evaluation of short and long-term post-operative complications and the cosmetic result.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who met all the following criteria were eligible for inclusion in this retrospective evaluation:
  • Male or female patients, living or deceased, aged 18 years or older at the time of operation
  • Unilateral (left/right) or bilateral lateral neck dissection along with central neck dissection
  • Patients with papillary cancer, pN1b. This excludes patients with other types of thyroid cancer (e.g., medullary, follicular, and anaplastic);
  • Patients that underwent central and/or lateral neck dissection as a primary intervention. This excludes patients with any previous operation for thyroid disease involving any type of lymph node dissection.
  • Exclusion criteria: patient's age < 18 years, patients that underwent previous neck dissection of any type and patients who refused or were unable to provide adequate follow up data.

排除标准

  • 未提供

结局指标

主要结局

Harvested lymph nodes

时间窗: Interventions 2018-2021, Final follow up January 2023

Total and positive lymph node yields for central and lateral compartments

Early loco-regional recurrence

时间窗: Interventions 2018-2021, Final follow up January 2023

Locoregional recurrence within 1 year from operation

次要结局

  • Cosmetic outcome(Interventions 2018-2021, Final follow up January 2023)
  • Early and late complications(Interventions 2018-2021, Final follow up January 2023)
  • Voice and swallowing score comparisons(Interventions 2018-2021, Final follow up January 2023)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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